This Article  • Full text  • PDF  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Contact me when this article is cited  Related Content  • Similar articles in JAMA  Social Bookmarking   What's this?

JAMA. 1998;279:346.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The FDA is implementing this major new legislation, which includes important provisions regarding patient access to experimental drugs and medical devices, information on clinical trials, pharmacy compounding, food safety and labeling, and other matters. One provision of the act abolishes a prohibition on manufacturers' dissemination of information about unapproved uses of drugs and devices, permitting them to disseminate peer-reviewed journal articles provided that they commit to file, within a specified time frame, an application to establish the safety and effectiveness of the unapproved use. The statute also adds a new provision that will require tracking of the status of postmarketing approval studies.

One of the most important pieces of the legislation is that which reauthorizes, for another 5 years, user fees paid by manufacturers for prescription drugs. During the previous 5-year period, funding from the fees provided the agency with resources to reduce from 30 months to 15 months the . . . [Full Text of this Article]

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?